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The Australian regulatory authority, the TGA, is taking steps to improve the existing regulation in the sphere of manufacturing and use of medical devices through what is known as the “Action Plan”. The main goal of...

The Australian medical device regulation authority, the Therapeutic Goods Administration (TGA), published proposed changes in March of 2019 that will affect the current classification system of medical devices. The...

The institution that oversees medical devices in Australia is the Therapeutic Goods Administration (TGA). The TGA has established the Australian Regulatory Guidelines for Medical Devices (ARGMD), which closely...

Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting...

The International Coalition of Medicines Regulatory Authorities (ICRMA) announced on Friday that they are seeking industry experts for a one year project to ensure proper awareness of track and trace systems for...

After a warning from the United States Food and Drug Administration (FDA) against using oral forms of anesthetic benzocaine in children under two for teething pain, Australia’s Therapeutic Goods Association (TGA)...